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Pharmaceutical Executive July 30, 2007 Jill Wechsler	Washington Report: Exclusivity vs. Patents To encourage innovation while supporting access to less costly therapies, Congress proposes an extensive data-exclusivity period that would delay Food and Drug Administration approval of a follow-on biologic application for 12 years.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
Managed Care April 2007 Martin Sipkof	Abbreviated Approval Process In the Works for 'Biosimilar' Drugs The Access to Life-Saving Medicine Act may be a first step to giving the FDA the legal authority to approve these drugs.
Pharmaceutical Executive September 1, 2011 Jill B. Conner	Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs.
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
The Motley Fool March 3, 2009 Brian Orelli	Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think.
Pharmaceutical Executive November 1, 2012 Jill Wechsler	Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
Pharmaceutical Executive June 1, 2009 John F. Kouten	On the Right Pathways With staggering year-over-year growth, biosimilars are "the future of medicine." Marketers must position their companies for the inevitable changes. President Barack Obama has pledged support for legislation governing biosimilars.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system.
Pharmaceutical Executive September 1, 2011 Jill Wechsler	Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.
Pharmaceutical Executive September 1, 2005 Jill Wechsler	Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
The Motley Fool October 26, 2007 Brian Orelli	Investing in Follow-On Biologics Investors, while approvals of follow-on biologics in the U.S. are probably still years away, now is the time to do your research. Those that are leading the race overseas are likely to be first in line when the FDA opens its door to applications.
The Motley Fool February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
The Motley Fool July 17, 2007 Brian Orelli	An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much.
The Motley Fool June 25, 2007 Brian Orelli	Leading the Pack of Follow-On Drug Makers Generic drug maker Dr. Reddy's Laboratories is taking a huge risk to get ahead of the pack, but it's well worth the rewards of being in front of its competitors. Investors, take note.
Pharmaceutical Executive February 1, 2011 Jill Wechsler	Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency
Pharmaceutical Executive October 1, 2012 J. Michael Nicholas	Complex Drugs and Biologics: Policy Considerations in Brazil The Brazilian government's policy on biologics doesn't adequately address non-biologic complex drugs. Additional guidance is needed to bring these important medicines to market.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
Chemistry World February 14, 2012 Rebecca Trager	FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.
Pharmaceutical Executive March 1, 2013 Jill Wechsler	Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year.
Managed Care January 2007 John Carroll	Debate Over Biologics Heats Up in Congress One of the possible issues is 'biosimilars,' agents that would fill the role that generics play in traditional pharmacy coverage.
Chemistry World January 9, 2015 Rebecca Trager	US poised to approve its first 'biosimilar' drug A key committee of the US Food and Drug Administration has voted in favor of licensing a copycat version of a biological drug. If approved, Sandoz's Zarxio (filgrastim) would be the first 'biosimilar' drug available in the US.
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
Pharmaceutical Executive January 1, 2006 Jill Wechsler	Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin.
Chemistry World March 25, 2010 Rebecca Trager	Big pharma scores in US healthcare reform President Obama has signed the biggest US healthcare reform since the 1960s, and although it is largely seen as a victory for the pharmaceutical industry, some analysts are characterising it as a 'double-edged sword'.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
Pharmaceutical Executive December 1, 2006 Jill Wechsler	Washington Report: The New Agenda Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda with drug pricing and access high on the list.
The Motley Fool June 11, 2009 Brian Orelli	The FTC Hates You, Too The agency weighs in (unhappily) on follow-on biologics.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices.
Managed Care February 2008 Martin Sipkoff	FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process?
Chemistry World April 24, 2008 James Mitchell Crow	FDA takes tough line on biologic drug The US Food and Drug Administration has rejected an application from biotechnology firm Genzyme to make its already-approved, protein-based drug Myozyme in larger batches.
Pharmaceutical Executive February 1, 2006 Sarah Houlton	Global Report: Moving Towards Generic Biologics The European Medicines Agency hopes to complete its guidelines for the approval of biosimilar drugs early this year, paving the way for the approval of biogenerics - and a potential goldmine for the generics companies.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
The Motley Fool September 23, 2008 Brian Lawler	Will Generic Biologics Get Special Treatment? While the rest of the market was lost in the financial meltdown, a little-noticed report discussing some of the biopharmaceutical bills going through Congress was released.
Pharmaceutical Executive December 1, 2013	FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.
Pharmaceutical Executive February 1, 2009 Jill Wechsler	Securing Savings A close look at the healthcare industry will separate real cost-cutting measures from money-saving myths.
Pharmaceutical Executive May 1, 2006 Jill Wechsler	Washington Report: Opportunity Knocks FDA has finally released its long-awaited list of research opportunities for the Critical Path initiative. Now comes the hard part, as companies learn how to collaborate on projects that will benefit pharma as a whole.
Pharmaceutical Executive April 1, 2011	Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access.
Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
Pharmaceutical Executive July 1, 2014 Jill Wechsler	Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.
Pharmaceutical Executive February 1, 2013 Jill Wechsler	Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.
Pharmaceutical Executive November 1, 2011 Jill Wechsler	The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices.
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
Pharmaceutical Executive October 1, 2012 Jill Wechsler	Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny.
Pharmaceutical Executive July 1, 2012 Jill Wechsler	Who Will Pay for New Drugs? Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies.